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Ketotifen Fumarate (Walgreens)

Available Formats

Dosage Form Package Information Links
SOLUTION/ DROPS 1 BOTTLE, DROPPER in 1 CARTON (0363-9060-00) > 10 mL in 1 BOTTLE, DROPPER Label Information

Complete Ketotifen Fumarate Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient

    Ketotifen (0.025%)

    (equivalent to ketotifen fumarate 0.035%)


  • Purpose

    Antihistamine


  • Uses

    Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.


  • Warnings

    Do not use
    • if solution changes color or becomes cloudy
    • if you are sensitive to any ingredient in this product
    • to treat contact lens related irritation

    When using this product
    • do not touch tip of container to any surface to avoid contamination
    • remove contact lenses before use
    • wait at least 10 minutes before reinserting contact lenses after use
    • replace cap after each use

    Stop use and ask a doctor if you experience any of the following:

    • eye pain
    • changes in vision
    • redness of the eye
    • itching worsens or lasts for more than 72 hours

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.


  • Directions

    • Adults and children 3 years of age and older:
      Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day.
    • Children under 3 years of age:
      Consult a doctor.

  • Other information

    • only for use in the eye
    • store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

  • Inactive ingredients

    Benzalkonium Chloride 0.01%, Glycerin, Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.


  • Questions or Comments?

    1-800-932-5676


  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    Well at

    Walgreens NDC 0363-9060-00

    STERILE ● ORIGINAL

    PRESCRIPTION STRENGTH

    Eye Itch Relief

    Ketotifen Fumarate

    Ophthalmic Solution

    Antihistamine Eye Drops 0.34 FL OZ (10 mL)

    Principal Display Panel Text for Container Label:

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    Well at

    Walgreens NDC 0363-9060-00

    WALGREENS PHARMACIST RECOMMENDED≠

    STERILE ORIGINAL

    PRESCRIPTION STRENGTH

    Eye Itch

    Relief

    Ketotifen Fumarate

    Ophthalmic Solution

    Antihistamine Eye Drops

    • Works in minutes
    • For ages 3 years & older
    • 60-day supply

    12

    HOUR

    0.34 FL OZ (10 mL)

    Compare to Alaway® active ingredient#

    Principal Display Panel Text for Carton Label

  • INGREDIENTS AND APPEARANCE
    KETOTIFEN FUMARATE 
    ketotifen fumarate solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9060
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ketotifen fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen 0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    benzalkonium chloride (UNII: F5UM2KM3W7)  
    glycerin (UNII: PDC6A3C0OX)  
    water (UNII: 059QF0KO0R)  
    hydrochloric acid (UNII: QTT17582CB)  
    sodium hydroxide (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-9060-00 1 in 1 CARTON 01/25/2013
    1 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077958 01/25/2013
    Labeler - Walgreens (008965063)
    Registrant - Akorn, Inc. (062649876)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc 603980319 MANUFACTURE(0363-9060) , ANALYSIS(0363-9060) , STERILIZE(0363-9060) , PACK(0363-9060) , LABEL(0363-9060)